Medical data management system

ABSTRACT

Data related to the adherence of a patient to a therapy regime can be collected from multiple medical devices, each of which may have an incomplete data set with data entries associated with times. Each incomplete data set represents a portion of a complete data set. The data sets can be integrated to create a complete data set with data entries from each incomplete data set being arranged in a temporal sequence with respect to one another. A report may be generated, the report having the data entries of the complete data set or a function of the data entries of the complete data set.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND Field of the Invention

The present invention generally relates to medical devices. Moreparticularly, the present invention relates to systems for themanagement of medical device data.

Description of the Related Art

In the long term treatment or monitoring of medical conditions, it iscommon for healthcare systems to handle such conditions on an outpatientbasis, e.g. at a residence of a patient rather than at a healthcarefacility. To treat or monitor the patient on an outpatient basis, thepatient may be prescribed a medical device that she may order from amedical device distributor or manufacturer and use at her place ofresidence. In many cases, if the patient is covered under a healthinsurance policy, the cost of the medical device may at least in part bepaid or reimbursed by an insurer. In some cases, the cost of the medicaldevice may at least in part be paid or reimbursed by a public healthcaresystem. The medical device may help the patient manage her medicalcondition by providing therapy or by obtaining and providing diagnosticdata to a physician or healthcare provider. In some cases, the medicaldevice may be given to the patient by a medical device distributor, whomay offer the patient the device without immediate compensation, but whomay be paid later by the insurer and/or healthcare provider. However, ifthe patient does not use the medical device on a regular basis to aid inthe management of her medical condition, the management of the medicalcondition may be less effective. To help to ensure that the fundsallocated by the insurer and/or healthcare system to at least in partpurchase the medical device are well spent, the insurer and/orhealthcare system may require the patient to provide evidence of regularuse of the medical device. If the patient cannot provide proper evidenceof regular use of the medical device, the insurer and/or healthcaresystem may opt to not subsidize the medical device purchase. The medicaldevice distributor may not be paid and may be forced to repossess themedical device. Additionally, in some cases, if the patient engages inhazardous work or work requiring careful attention to detail, thepatient's employer may require evidence of regular use of the medicaldevice. If the patient cannot provide proper evidence of regular use ofthe medical device, to reduce the employer's liability, the employer maybe forced to terminate the patient's employment. Furthermore, if thepatient requires a license to engage in the work, the patient's licenseto handle the particular line of work (normally issued by a local orstate government body) may be rescinded.

As such, it is important to be able to provide evidence of use of amedical device. This evidence may come in the form of a set of dataindicating when and/or how the medical device was used over a period oftime. This evidence may be referred to as the evidence of compliance oradherence, and the set of data may be referred to as compliance oradherence data (hereinafter, in this section referred to as evidence ofcompliance and compliance data, respectively). To both aid the patientin collecting and managing compliance data and reassure the medicaldevice distributor that servicing the patient will result inreimbursement, many medical devices offer compliance data managementsolutions. In some cases, the medical device may automatically recordthe compliance data over the time period over which the patient uses thedevice and upload the data to a removable storage medium. The removablestorage medium may be given to a physician, insurer, and/or medicaldevice distributor. In some cases, the medical device may output encodedmessages that the patient may manually input into compliance monitoringdatabase, which may be on the internet, on a handheld monitoring device,or elsewhere. In some cases, the medical device may automaticallywirelessly transmit compliance data to a compliance monitoring databasethrough the use of wireless data communications technologies.

SUMMARY OF THE INVENTION

Some patients may wish to carry multiple medical devices that may beused interchangeably to treat and/or monitor their medical condition. Insome cases, the patient may want a first high-end medical device totreat her condition at home and a second smaller or ‘moretravel-friendly’ device to use when away from home for an extendedperiod of time. For example, when considering obstructive sleep apnea(OSA), a patient who is a truck driver may wish to use a high-endpositive airway pressure (PAP) device to treat her OSA at home and wishto use a lightweight travel-friendly PAP device to treat her OSA whenworking or otherwise away from home. However, compliance data managementmay become more difficult when two or more medical devices are used. Insome cases, if the patient uses multiple devices over a given timeperiod, the patient may forget to send compliance data for one or moreof the devices and, in such cases, there may be gaps in the compliancedata reported to a recipient (e.g., an insurer, a medical devicedistributor, etc.). In some such cases the patient may have moredifficulty providing proper evidence of compliance to the recipient. Insome cases, the patient may be forced to send two separate sets ofcompliance data and the recipient may have the added challenge ofmanually integrating the two sets of data to compile a single set ofaccurate compliance data. In either case, the tasks related tocompliance data management may become more inconvenient for the patientand/or for the recipient. Accordingly, it is an object of the disclosureto provide improved data management solutions that may solve one or moreof the above problems, or at least provide the public with a usefulchoice.

In accordance with at least one of the embodiments disclosed herein is amethod of integrating data from two or more medical devices comprising:receiving a first data set comprising one or more data entries relatedto the use of a first medical device, related to the therapy of apatient using the first medical device, and/or related to a patientusing the first medical device, each of the one or more data entriesbeing associated with a time and/or a position in a sequence of entries,receiving a second data set comprising one or more data entries relatedto the use of a second medical device, related to the therapy of apatient using the second medical device, and/or related to a patientusing the second medical device, each of the one or more data entriesbeing associated with a time and/or a position in a sequence of entries,and integrating the first data set with the second data set to create athird data set, the integration being such that the third data setcomprises the data entries of the first and second data sets.

In some configurations a report is generated comprising the third dataset and/or a function of the data entries of the third data set.

In some configurations the integration is such that the third data setcomprises the data entries of the first and second data sets arranged ina temporal sequence with respect to one another.

In some configurations the first and second medical devices are PAPdevices.

In some configurations the first data is received from a first device.Optionally the first data is received from the first device via aninternal and/or peripheral data communications module of the firstand/or a second device.

In some configurations the first data is received from the first devicevia an intermediary device.

In some configurations the first device is one of:

-   -   the first medical device, or    -   a proxy device.

In some configurations the second data is received from a second device.Optionally the second data is received from the first device via aninternal and/or peripheral data communications module of the secondand/or first devices.

In some configurations the second data is received from the seconddevice via an intermediary device.

In some configurations the second device is one of:

-   -   the second medical device, or    -   a proxy device.

In some configurations the first data set is received at the seconddevice.

In some configurations the second data set is received at the firstdevice.

In some configurations the first and/or second data sets are received ata third device, such as a server.

In some configurations the report comprises information related to theadherence of a patient to a therapy regime.

In some configurations if the third data set comprises more than onedata entry associated with the same time, a fault signal is generated.

In some configurations all of the data entries of the first set and allof the data entries of the second set are related to the same patient.

In some configurations the third data set is sent to both the firstdevice and the second device.

In some configurations the first and second data sets are overwritten bythe third data set.

In some configurations the function of the data entries of the thirddata set comprises an indicator related to the adherence of a patient toa therapy regime.

In some configurations the indicator comprises a binary indicatorindicating the adherence of a patient to a therapy regime relative to athreshold level of adherence.

In some configurations the indicator comprises a qualitative indicatorrelated to the degree of adherence of a patient to a therapy regime.

In some configurations the method of data integration is performed bythe first device and/or by the second device.

In some configurations the method of data integration is performed by athird device remote from the first device and/or the second device, thethird device optionally being the intermediary device.

In some configurations the method or system further comprisesidentifying data entries of the first data set that are coincident withdata entries of the second data set based on a time stamp recorded foreach data entry using clocks in the first and second devices.

In some configurations the method or system further comprisessynchronizing a clock in the first device with a clock in the seconddevice. Optionally, the clocks are synchronized by coupling the firstand second devices. Optionally the clocks are synchronized usingexternal time signals, such as GPS timing signals.

In some configurations, a time stamp window is used to identifycoincident data entries that have time stamps with time stamp windowsthat overlap.

In some configurations, the plausibility of data entries from the firstand second devices is determined based on the time difference betweenthe respective data entry time stamps, and the respective geographicallocations of the first and second devices. In some configurations, ananomaly is determined if the data entries from the first and seconddevices are within a time window (time range) that is commensurate withthe geographical separation of the devices. In some configurations, thewindow is set manually or automatically based on the geographicalseparation. In some configurations, the time window is set using a lookup table correlating time ranges for geographical separations. Thegeographical separations could be determined using GPS locationtechnology on each device.

In accordance with at least one of the embodiments disclosed herein is adata management system comprising a controller configured to: receive afirst data set comprising one or more data entries related to the use ofa first medical device, related to the therapy of a patient using thefirst medical device, and/or related to a patient using the firstmedical device, each of the one or more data entries being associatedwith a time and/or a position in a sequence of entries, receive a seconddata set comprising one or more data entries related to the use of asecond medical device, related to the therapy of a patient using thesecond medical device, and/or related to a patient using the secondmedical device, each of the one or more data entries being associatedwith a time and/or a position in a sequence of entries, and integratethe first data set with the second data set to create a third data set,the integration being such that the third data set comprises the dataentries of the first and second data sets.

In some configurations the controller is configured to generate a reportcomprising the third data set and/or a function of the data entries ofthe third data set.

In some configurations the controller is configured to integrate thefirst data set with the second data set such that the third data setcomprises the data entries of the first and second data sets arranged ina temporal sequence with respect to one another.

In some configurations the first and second devices are PAP devices.

In some configurations the first data is received from a first device.Optionally the first data is received from the first device via aninternal and/or peripheral data communications module of the firstand/or a second device.

In some configurations the first data is received from the first devicevia an intermediary device.

In some configurations the first device is one of:

-   -   the first medical device, or    -   a proxy device.

In some configurations the second data is received from a second device.Optionally the second data is received from the first device via aninternal and/or peripheral data communications module of the secondand/or first devices.

In some configurations the second data is received from the seconddevice via an intermediary device.

In some configurations the second device is one of:

-   -   the second medical device, or    -   a proxy device.

In some configurations the first data set is received at the seconddevice.

In some configurations the second data set is received at the firstdevice.

In some configurations the first and/or second data sets are received ata third device, such as a server.

In some configurations the report comprises information related to theadherence of a patient to a therapy regime.

In some configurations if the third data set comprises more than onedata entry associated with the same time, a fault signal is generated.

In some configurations all of the data entries of the first set and allof the data entries of the second set are related to the same patient.

In some configurations the third data set is sent to both the firstdevice and the second device.

In some configurations the first and second data sets are overwritten bythe third data set.

In some configurations the function of the data entries of the thirddata set comprises an indicator related to the adherence of a patient toa therapy regime.

In some configurations the indicator comprises a binary indicatorindicating the adherence of a patient to a therapy regime relative to athreshold level of adherence.

In some configurations the indicator comprises a qualitative indicatorrelated to the degree of adherence of a patient to a therapy regime.

In some configurations the first and second data sets are eachassociated with a patient.

In some configurations the first and second data sets are associatedwith the same patient.

In some configurations if the first and second data sets are notassociated with the same patient, a fault signal is generated.

In some configurations if the first and second data sets are notassociated with the same patient, the report comprises an error message.

In some configurations the first device is the first medical device andthe second device is the second medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

Specific embodiments and modifications thereof will become apparent tothose skilled in the art from the detailed description herein havingreference to the figures that follow, of which:

FIG. 1 is schematic diagram of a data communication system.

FIG. 2 is a schematic diagram illustrating a method of datasynchronization.

FIG. 3 is a schematic diagram illustrating a method of datasynchronization.

FIG. 4 is a schematic diagram illustrating a method of datasynchronization.

FIG. 5 is a schematic diagram illustrating a method of datasynchronization.

FIG. 6 is a schematic diagram illustrating a method of datasynchronization.

FIG. 7 is a schematic diagram illustrating a method of datasynchronization.

FIG. 8 is an illustration of an output module of a device.

FIG. 9 is an illustration of an output module of a device.

FIG. 10 is a flow chart illustrating certain features, aspects and/oradvantages of some configurations of the present disclosure.

FIG. 11 is an illustration of an output module of a device.

FIG. 12 is an illustration of an output module of a device.

FIG. 13 is an illustration of a medical device (e.g. a breathingassistance apparatus).

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

Certain features, aspects and advantages of at least one of theconfigurations disclosed herein include the realization that partialsets of compliance data can be taken from multiple separate medicaldevices and integrated such that a single complete set of compliancedata can be obtained. The single complete set can be transferred to oneor more of the medical devices, to a physician, to an insurer, or toanother person, apparatus, or system. In some cases, a report disclosingthe adherence of a patient to a therapy regime may be generated. Thereport may be sent to one or more of the medical devices, to aphysician, to an insurer, or to another person, apparatus, or system.

Embodiments described herein relate to merging data from two or moremedical devices, such as (but not limited to) a breathing assistanceapparatus 102/108 shown schematically in FIG. 13 . The breathingassistance apparatus 102/108 shown in FIG. 13 could be a pressuretherapy apparatus (such as a CPAP apparatus or similar) or it could be aflow therapy apparatus. Either way, the apparatus comprises a housing 1with a flow generator 2 (blower), humidifier 3, sensors (in suitablelocations such as 4 a, 4 b, 4 c) and a controller 5 for controlling theflow generator 2 and humidifier 3. The controller 5 operates the flowgenerator 2 to draw in ambient gas 6 (e.g. air) and pass a flow of gasesthrough the humidifier 3 which is operated to humidify the gases. Thegases are delivered to a patient 9 via a delivery conduit 7 and patientinterface 8. Various flow, humidity, temperature, pressure and othersensors 4 a-4 c can be arranged throughout the system to providefeedback to the controller 5 for control of the flow generator 2 and/orhumidifier 3. In a pressure therapy apparatus, the patient interface 8forms a seal around the mouth and/or nose of the patient 9 and thecontroller 5 controls the flow generator 2 to create a controlledpressure for delivery to the patient interface 8 and ultimately thepatient 9. In a flow therapy apparatus, the controller 5 operates theflow generator 2 to create a controlled flow for delivery to the patientinterface 8 and ultimately the patient 9.

With reference to FIG. 1 , a schematic diagram of a data communicationsystem involving a plurality of devices (such as shown in FIG. 13 ) isshown. A first device 102 is illustrated. The first device 102 may be amedical device, e.g., a positive airway pressure (PAP) therapy device.The first device 102 may comprise a first data communication module 104.The first data communication module 104 may directly and/or indirectlysend and/or receive data to and/or from other devices. In someconfigurations, the first data communication module 104 may be a part ofor integrated with the first device 102. In some configurations, a firstperipheral data communications module 106 may be physically connected(e.g. through wired communication technologies such as USB, RS232,Ethernet, I2C, and/or other technologies) and/or wirelessly connected(e.g. through wireless communication technologies such as Bluetooth,WiFi, near field communications (NFC), and/or other technologies) to thefirst device 102. The first peripheral data communications module 106may directly and/or indirectly send and/or receive data to and/or fromother devices. A second device 108 is illustrated. The second device 108may be a medical device, e.g. a positive airway pressure (PAP) therapydevice. Similarly, the second device 108 may comprise a second datacommunication module 110. The second data communication module 110 maydirectly and/or indirectly send and/or receive data to and/or from otherdevices. In some configurations, the second data communication module110 may be a part of or integrated with the second device 108. In someconfigurations, a second peripheral data communications module 112 maybe physically connected (e.g. through wired communication technologiessuch as USB, RS232, Ethernet, I2C, and/or other technologies) and/orwirelessly connected (e.g. through wireless communication technologiessuch as Bluetooth, WiFi, near field communications (NFC) and/or othertechnologies) to the second device 108. The second peripheral datacommunications module 112 may directly and/or indirectly send and/orreceive data to and/or from other devices. The first and second devices102, 108 may communicate with each other. In some configurations, thefirst and second devices 102, 108 may communicate with each otherthrough the first and second data communication modules 104, 110. Thecommunication may be through the use of wired or wireless communicationsstandards or technologies similar to those described above. In someconfigurations, the first device 102 may communicate with the secondperipheral data communications module 112 through the first datacommunications module 104. In some configurations, the second device 108may communicate with the first peripheral data communications module 106through the second data communication module 110. In someconfigurations, the first 102 and second 108 devices might communicatewith each other through the first 106 and second 112 peripheral datacommunications modules. Any of these communications may proceed via orthrough an intermediary device 114. The intermediary device 114 may be amedical device (e.g. a PAP device), a remote computing system (such as adesktop computer, a laptop computer, a tablet, a mobile phone, or awearable computing system such as a ‘smart watch’), a wide area network(WAN), such as the internet or a cloud computing network, or anotherintermediary device.

Data can be transferred as described above and/or shown in FIG. 1 forthe purposes of merging data sets from two or more devices. Data mergingcan be done in the first device 102, the second device 108, theintermediary device 114, in one or more other devices, or in anycombination of one or more of the aforementioned devices. It should benoted therefore that the intermediary device 114 may provide acommunications conduit between the first 102 and second 108 devices, mayconduct data merging, or both.

As shown in FIG. 1 , a first data set 118 (which, for example, may beheld in a memory media of the first device 102) may be transmitted fromthe first device 102 to the second device 108 using any of thecommunication channels described. For example, the first data set 118could be transmitted directly between the first data communicationsmodule 104 and the second data communications module 110. Alternatively,in some configurations, the first data set 118 may be transmitted fromthe first device 102 through the first data communications module 104 tothe first peripheral data communications module 106, and the firstperipheral data communications module 106 may transmit the first dataset 118 to the second device 108 through the second data communicationsmodule 110. In some configurations, the first data set 118 may betransmitted from the first device 102 through the first datacommunications module 104 to the first peripheral data communicationsmodule 106, then from the first peripheral data communications module106 to the second peripheral data communications module 112, and thenfrom the second peripheral data communications module 112 to the seconddevice 108 through the second data communications module 110. In someconfigurations, data may be transmitted from the first device 102through the first data communications module 104 to the secondperipheral data communications module 112, and then to the second device108 through the second data communications module 110. Other methods oftransferring data can also be undertaken as previously described aboveand/or as shown in FIG. 1 or as previously described with reference toFIG. 1 for transferring the first data set 118. Equivalent methods tothose described can also be used for transferring a second data set 120(which may, for example, be held in a memory media of the second device108) from the second device 108 to the first device 102. In someconfigurations, the first device 102 and the second device 108 may sendthe first data set 118 and the second data set 120 to the intermediarydevice 114 without communication between the first device 102 and thesecond device 108. The intermediary device 114 can act as a conduit totransfer data sets between the first and/or second devices 102, 108and/or can process the data sets to merge it or facilitate the merging.Data merging could alternatively occur in the first and/or seconddevices 102, 108 and/or in another device.

The type or nature of the data (in the data sets) obtained, received,and/or transmitted by the first device 102 and/or the second device 108is not limited. In some configurations, the data comprises data relatedto the adherence of a patient to a therapy regime. In someconfigurations, the first data may comprise data related to the use ofthe first device 102, data related to therapy of a patient using thefirst device 102, and/or data related to a patient using the firstdevice 102. The second data may comprise data related to the use of thesecond device 108, data related to therapy of a patient using the seconddevice 108, and/or data related to a patient using the second device108. In some configurations, and as described with reference to FIG. 13, the medical devices may be PAP devices. The data may comprise, forexample, compliance data, AHI (apnea-hypopnea index) data, sleep qualitydata, data related to the number of hours the medical devices were used,or other types of data.

The first and second data sets 118, 120 contain data in the form of oneor more data entries, each optionally in one or more data blocks (see,e.g., FIG. 2 ). The data entries of the respective first and second datasets 118, 120 can be collected and/or recorded by the first and seconddevices 102, 108 or by other means. The first 102 and second 108 devicesalso each comprise a clock 109, 107. The clock can be anything thatprovides a timing reference/signal, and can be external or internal, andcan be or comprise timing signals that originate from an external source(e.g., GPS). Using the clock, each data entry receives a time stamp thatassociates the data entry with a time. Each data block, and data set canalso receive a suitable time stamp. This provides a time and/or positionof the each data entry, data block, and/or data set in a temporalsequence.

In alternative configurations, the first device 102 and/or second device108 may not be medical devices. In some such configurations, the firstand/or second devices 102, 108 may, for example, comprise proxy devicescomprising data from medical devices (e.g. the medical devices describedelsewhere in this disclosure with reference to FIG. 13 ). The proxydevices may receive data from the medical devices and integrate datareceived in a similar manner. Similar features, aspects and advantagesof the systems, apparatus and methods of the present disclosure madewith reference to the first and/or second devices 102, 108 being medicaldevices may be envisioned in some such cases where the first and/orsecond devices 102, 108 are not medical devices.

FIG. 2 demonstrates a data integration method illustrating certainfeatures, aspects and/or advantages of some configurations of thepresent disclosure. It should be understood that the word ‘integration’or derivatives thereof may mean ‘merging,’ ‘combining,’ ‘joining,’‘unifying,’ ‘compounding,’ and/or ‘amalgamating.’ As described before,data can be transferred and/or merged by any of the devices of FIG. 1 .As non-limiting example, a method of transferring data and merging it inthe intermediary device 114 is shown in FIG. 2 . A first-data set 118 isshown in FIG. 2 . The first data set 118 may comprise a first data 113.The first data 113 may be obtained from the first device 102 over aperiod of time Tp. The first data 113 may comprise data blocks 113A,113B, the data blocks 113A, 113B each comprising one or more timestamped data entries—that is, the data entries may each be associatedwith a time. The time may be when the particular data entry was created.A time can be associated with each data block and also the data set,either via time stamp or inferred from the data entry time stamps. Inthe illustrated configuration, the first data 113 may be noncontiguousbetween a first time T1 and a second time T2 over the period of time Tp,e.g., the first data 113 may comprise one or more gaps or missingentries in the first data 113 over the period of time Tp. The first dataset 118 may be communicated by the first device 102 to the intermediarydevice 114. Similarly, a second data set 120 is shown. The second dataset 120 may comprise a second data 116 obtained from the second device108 over the period of time Tp. The second data 116 may be in the formof a block of data, the block of data comprising one or more dataentries. The data entries may each be associated with a time. In theillustrated configuration, the second data set 120 may be contiguousbetween a third time T3 and a fourth time T4, but there may still begaps or missing entries over the period of time Tp because the range oftimes bounded by the third time T3 and the fourth time T4 may be asubset of the period of time Tp. The second data set 120 may becommunicated by the second device 108 to the intermediary device 114.The intermediary device 114 may compare the first data set 118 with thesecond data set 120. If the period of time Tp related to the first dataset 118 is the same as the period of time Tp related to the second dataset 120, and if the first and second data sets 118, 120 together do notcomprise multiple data entries associated with the same time, then theintermediary device 114 may integrate the first and second data sets118, 120 to create a third data set 122. The integration may be suchthat the data entries of the first data set 118 and the data entries ofthe second data set 120 are arranged in order such that the timesassociated with the data entries are set in a temporally sequentialorder with respect to one another. For example, in the illustratedconfiguration, the first and second data sets 118, 120 may be arrangedsuch that the first data block 113A of the first data 113 comes first,the data block of the second data 116 comes second, and the second datablock 113B of the first data 113 comes third, such that the third dataset 122 comprises data entries of the first data 118 and the second dataset 120 arranged in temporal succession and such that the third data set122 represents a complete set of data spanning over the period of timeTp. As shown in FIG. 2 , and the alternative examples of FIGS. 3 and 4 ,any number of data blocks or data entries of the first and second datasets 118, 120 may be integrated in a similar manner to create a thirdcomplete data set 122. In addition, it should be understood that themethod of integration is not limited to two data sets, but any number ofdata sets from any number of devices may be integrated in similarmanners to create a complete data set.

The third data set 122 may be used to generate a report comprising theentries of the third data set 122 and/or one or more functions of one ormore entries of the third data set 122. For example, if the data of thefirst data set 118 and of the second data set 120 is related to theadherence of a patient to a therapy regime, the report may compriseinformation summarizing the patient's adherence to the therapy on atherapy session-by-therapy session basis, a night-by-night basis, or onsome other basis. The report may comprise a binary indicator (e.g.‘yes,’ ‘no,’ ‘true,’ ‘false,’ ‘pass,’ ‘fail,’ etc) derived from the dataentries indicating whether the patient succeeded or did not succeed inachieving a level of adherence to a therapy regime relative to athreshold level of adherence. The report may comprise a qualitativeindication (e.g. ‘great,’ ‘good,’ ‘fair,’ ‘poor,’ etc) derived from thedata entries indicating the degree of adherence of a patient to atherapy regime. The degree of adherence may be compared to one or morethreshold or baseline values to derive the qualitative indication.

It will be appreciated that using the intermediary device 114 and datatransfer modes as described with respect to FIG. 2 is just one option.It will be appreciated other modes of transfer and merging data could bedone alternatively. For example, in some configurations, and asillustrated in FIG. 6 , a method of data integration similar to thatillustrated in FIG. 2 and in the above passages may be used. However,instead of transferring data to an intermediary device 114 andformulating the third data set 122 at the intermediary device 114, insome configurations the first device 102 and the second device 108 may‘swap’ data—in other words, the first device 102 may receive the seconddata set 120 from the second device 108 and the second device 108 mayreceive the first data set 118 from the first device 102. In some suchconfigurations, data integration may occur at both the first device 102and the second device 108 so that each of the first device 102 and thesecond device 108 comprises a copy of the third data set 122. The taskof data management may then become easier for a user such as a patientbecause the user need only upload data from one of the devices ratherthan both of the devices—in addition, if the user misplaces one of thedevices, a complete third data set 122 is still capable of beinguploaded by the user using the other device. In some configurations,data may be transmitted in only one direction (e.g. transmission of thefirst data set 118 from the first device 102 to the second device 108 ortransmission of the second data set 120 from the second device 108 tothe first device 102). In some such configurations, the method of dataintegration may only take place at one of the devices. After dataintegration, the complete third data set 122 may be sent from one of thedevices to the other device such that both devices have a copy of thethird data set 122. In some configurations, the third data set 122 mayoverwrite the first data set 118 and/or the second data set 120 in thememory of the first device 102 and/or the memory of the second device108. The first and second devices 102, 108 may communicate using manymeans, the means including wireless communication technologies such asBluetooth, WiFi, near field communications (NFC) and/or othertechnologies. In some configurations, the method of data integration mayproceed automatically. The first device 102 may automatically sense thepresence of the second device 108, or likewise the second device 108 maysense the presence of the first device 102, and either device mayautomatically initiate the data integration method upon sensing thepresence of the other device. In some configurations, if the presence ofa device has been determined, one of the devices 102, 108 may prompt auser for input related to the data integration. For example, and asdemonstrated in FIG. 11 , the second device 108 may query the user forconfirmation through an output module 132 of the second device 108,which may include one or more screens, microphones, and/or tactileindicators. A user, such as a patient, may use an input module 133 torespond positively or negatively to the query in order to authorize ordecline the data integration (e.g., ‘synchronization’). The input module133 may comprise one or more buttons, knobs, dials, switches, levers,microphones, and/or touch screens allowing configuration of the seconddevice 108. In some configurations, the user may manually requestintegration of the data sets. As demonstrated in FIG. 9 , the requestmay proceed by using the input module 133 to navigate a menu of theoutput module 132 and/or select a data integration (e.g.,‘synchronization’) option. In some configurations, and as demonstratedin FIG. 12 , if the presence of a compatible device is not determined,the option to integrate data may not be present, or may be obscuredand/or not selectable by the user.

In some configurations, and as illustrated in FIG. 7 , a method of dataintegration similar to that illustrated in FIG. 2 and in the abovepassages may be used. However, instead of transferring data to anintermediary device 114 and formulating the third data set 122 at theintermediary device 114, in some configurations the first device 102 maycopy the first data set 118 from a first memory media 128 of the firstdevice 102 to a peripheral data storage medium 126. The peripheral datastorage medium 126 may be inserted into a first accessory compartment124 of the first device 102. The peripheral data storage medium 126 maybe transferred from the first accessory compartment 124 of the firstdevice 102 to a second accessory compartment 129 of the second device108. The peripheral data storage medium 126 may communicate with asecond memory media 130 of the second device 108 such that the seconddevice 108 may perform the method of data integration using the firstdata set 118 stored on the peripheral data storage medium 126 and thesecond data set 120 stored on the second memory media 130. The completethird data set 122 obtained may be stored on the peripheral data storagemedium 126. The peripheral data storage medium 126 may be removed fromthe second device 108 and may be physically given to a recipient (e.g.an insurer, a medical device distributor, a physician, or some otherparty) via mail, courier service, or via some other means. Again, itshould be understood that this method of data integration is notnecessarily limited to the use of only two devices. Data from any numberof devices may be integrated.

Upon inserting the peripheral data storage medium 126 into the secondaccessory compartment 129 of the second device 108, the method of dataintegration of the first data set 118 and the second data set 120 mayproceed automatically, e.g. without any involvement or input of/from theuser. In alternative configurations, and as demonstrated in FIG. 8 , thesecond device 108 may output a query to an output module 132 of thesecond device 108 which may include one or more screens, microphones,and/or tactile indicators. A user such as a patient may use an inputmodule 133 to respond positively or negatively to the query in order toauthorize or decline the data integration (e.g., ‘synchronization’). Theinput module 133 may comprise one or more buttons, knobs, dials,switches, levers, microphones, and/or touch screens allowingconfiguration of the second device 108. In some configurations, and asdemonstrated in FIG. 9 , the user may manually request integration ofthe data sets. The request may proceed by using the input module 133 tonavigate a menu of the output module 132 and/or select a dataintegration (e.g., ‘synchronization’) option. It should be understoodthat similar methods could be implemented using the first device 102instead of the second device 108.

In the examples above, the data sets have data blocks with data entriesthat are not coincident in time. That is, the time stamps/timeassociated with each data entry is different from all the other entries.This is the normal situation—data entries should all have non-coincidenttimes as two or more devices should not/cannot be used by the sameperson simultaneously. However, anomalous situations may arise where twoor more data entries have coincident time stamps. Most likely, thismeans there is a problem. To improve data integrity, as describedpreviously, during integration of the two or more datasets, data entriesfrom different medical devices associated with the same time (coincidentdata entries) are identified for further action. It is useful toidentify anomalous coincident data entries, as this indicates a possibleerror in the respective clocks, in data collection, in use of thedevices or the like. It can indicate that the clocks are wrong, thatdifferent people are using the devices so the data entries do not relateto the same person and/or that data lacks integrity due to incorrectrecordal, malfunction in either of the medical devices, and/orinadvertent or deliberate misuse of the medical devices. If two medicaldevices are geographically remote from each other, it is not possiblefor a patient to use both at once. Even if two devices are not remote,they cannot and should not be used simultaneously by the same person.Therefore, any data entries associated with the same time across two ormore devices should be flagged as an error and/or follow up actiontaken. For example, a warning can be provided, coincident data deleted,or one coincident data entry can overwrite the other.

The integrity of this identification of coincident data entries relieson synchronization of the internal clocks of the medical devices fromwhich each data set comes—otherwise, there can be no confidence thatdata entries with the same time stamp did in fact get recorded at thesame time. In this case, there may not actually be a problem withcoincident data entries, just a perceived problem which could lead to afalse positive leading to unnecessary follow up action.

If the respective internal clocks of each medical device are notsynchronized, this undermines the identification of coincident dataentries. This can cause the following problems when merging data sets.

-   -   Coincident medical data entries that actually occur at the same        time across different medical devices are not identified as such        because the timestamps are not the same due to clock        de-synchronization.    -   Non-coincident data entries that do not occur at the same time        are incorrectly identified as being coincident as the        unsynchronized clocks inadvertently record the same time for        medical data entries that were in fact temporally separated.

The embodiments described herein can be adapted with one or acombination of the following to ameliorate the problems described above.

First, synchronization techniques can be used to synchronize the clocksof various medical devices. This could be achieved by physical, wirelessor other communicative coupling between the medical devices continuouslyor periodically to synchronize the clocks. For example, the medicaldevices could communicate their clock signals via wireless technologieswhen in range of each other to effect synchronization. Alternatively, oradditionally, GPS or other external timing signals could be used tocreate synchronized clock signals in the medical devices.

Second, when identifying coincidence of data entries from differentmedical devices, a time stamp window is optionally used to establishcoincidence. This is useful for dealing with the problem of respectivedevice clocks only being slightly de-synchronised. Rather than requiringan exact time match between the time stamps of two data entries toestablish coincidence, a time window (tolerance or time range) isallowed around each time stamp. If the time window of each data entrybeing compared overlaps to at least some degree, then it is determinedthat the data entries are coincident in time. The time window could beany suitable window, such as the time stamp+/−1 second (or any othertolerance range between 0 and 1 second, or even a tolerance range above1 second). The window should be specified to be large enough tocompensate for a likely magnitude of de-synchronization, but not solarge as to cause two non-coincident data entries to be falselyidentified as coincident.

Other difficulties may arise when the first device 102 and the seconddevice 108 are set to different times and/or are incapable ofmaintaining synchronicity with a reference time (e.g. a time found on anatomic clock, a time associated with a GPS signal, etc).

In such situations, the data entries of the first data set 118 and thedata entries of the second data set 120 may be difficult to integratebecause some of the data entries may be associated with the same timewhen in fact they did not occur at the same time. The report generatedfrom the third data set 122, if assembled from such data sets 118, 120,may be confusing to read and may not accurately portray, for example,the adherence of a patient to a therapy regime. In some configurations,a patient may attempt to integrate data from the first device 102 andthe second device 108, where the first device 102 and the second device108 were used by different patients. In some such configurations, if notwo data entries of the third data set 122 are associated with the sametime, the report generated from the third data set 122 may stillcomprise misleading information because data from more than one patienthas been utilized in the generation of the report. In someconfigurations, two successive entries of the third data set 122 may beassociated with times that are too far apart from one another to beplausible. For example, the entries may be associated with times thatare 50 years apart. In some configurations, and as demonstrated in FIG.5 , the entity performing the method of data integration, for example,the first device 102, the second device 108, and/or the intermediarydevice 114, may fail to integrate the first data set 118 with the seconddata set 120 on at least one of the above bases or on some other basisand generate a fault signal and/or error message. The fault signaland/or error message may be added to the report generated from the thirddata set 122, and/or may be reported to a patient and/or other userthrough an output module of the entity. In some configurations, if dataentries of the first data set 118 are associated with times that matchtimes associated with data entries of the second data set 120, theentity may prompt the user to select a dominant data set that mayoverwrite parts of the other data set to generate the third data set122. In some configurations, if data entries of the first data set 118are associated with times that match times associated with data entriesof the second data set 120, the dominant data set may automatically beselected and be used to overwrite the other data set and generate thethird data set 122. In some such configurations, the automatic dataoverwriting procedure may only take place if the temporal length of dataoverlap (for example, for a given pair of data blocks or for a givenpair of data sets) is less than or equal to a predetermined period oftime (e.g. 5 minutes). If the temporal length of data overlap is greaterthan the predetermined period of time, the entity may generate a faultsignal or an error message as described above. Individual data entriesmight be deleted or overwritten in the alternative.

Even if data entries across two or more devices are not coincident intime, they could still be anomalous and require follow up action. Forexample, two devices that are separated by a significant geographicaldifference might record data entries with time stamps that are clearlyat different times (that is not coincident, even taken into account thetime stamp window/tolerance), and record data entries. However, if thetime difference is not large/commensurate with the geographicaldifference, it would be impossible/implausible for both data entries tobe recorded on each device and relate to use by the same patient. Forexample, if the two medical devices are across town from each other, buthave data entries only separated by 5 minutes, clearly there is anerror. It would not be possible for the same patient to use one device,record a data entry, drive across town, use the other device and recordanother time entry all within 5 minutes. It indicates that the clocksare wrong, that different people are using the devices so the dataentries do not relate to the same person and/or that data lacksintegrity due to incorrect recordal, malfunction in the medical device,and/or inadvertent or deliberate misuse of the medical devices. Tocompensate for this, a time window can be used (which is similar to butdifferent from the time stamp window). This could be manually orautomatically set to a time window/range that is commensurate to thegeographical distance between devices. For example, for devices that arein the same residence, the time range might only be a minute or two. Ifthe devices are in different parts of a city, the time range might be inthe order of 20 minutes to an hour or two. If the devices are indifferent parts of a country or even the world, then the time rangecould be several hours or days. The time range could be altered as andwhen the devices move relative to each other. In some configurations,the devices could be tracked using GPS or other tracking technology, andtheir relative distance determined. The time range could then be setautomatically based on the relative distance, for example using a lookup table which correlates time ranges for different geographicalseparations of devices.

In summary, in accordance with certain features, aspects and advantagesof at least one of the embodiments disclosed herein, a method formerging or integrating data is disclosed. The method may comprisereceiving a first data set from a first device. The first data set maycomprise one or more data entries. One or more of the data entries maybe related to the use of a first medical device, related to the therapyof a patient using the first medical device, and/or related to a patientusing the first medical device. One or more of the data entries may beassociated with a time and/or a position in a sequence of entries. Insome configurations, each or all of the data entries may be associatedwith a time and/or position in a sequence of entries. The method maycomprise receiving a second data set from a second device. The seconddata set may comprise one or more data entries. One or more of the dataentries may be related to the use of a second medical device, related tothe therapy of a patient using the second medical device, and/or relatedto a patient using the second medical device. One or more of the dataentries may be associated with a time and/or a position in a sequence ofentries. In some configurations, each or all of the data entries may beassociated with a time and/or a position in the sequence of entries. Thefirst data set and the second data set may be integrated. Theintegration may lead to the creation of a third data set. Theintegration may be such that the third data set comprises the dataentries of the first data set and the second data set. In someconfigurations, the third data set comprises the data entries of thefirst data set and the second data set, the data entries ordered orarranged such that they are in a temporal sequence with respect to oneanother. A report may be generated comprising information related to thethird data set and/or information related to a function of the dataentries of the third data set.

In some configurations, the first device and/or the second device may bemedical devices. In some configurations, both the first and seconddevices are medical devices. In some configurations, the first device isthe first medical device and the second device is the second medicaldevice. In some configurations, the first and/or second devices are PAPdevices. In some configurations, the report may comprise informationrelated to the adherence of a patient to a therapy regime. In someconfigurations, if the third data set comprises more than one data entryassociated with the same time, a fault signal may be generated. In someconfigurations, a data management system may perform the method of dataintegration. In some such configurations, if the data management systemdetermines that data entries of the first data set are associated withtimes that are the same as times associated with data entries of thesecond data set, a fault signal may be generated. In someconfigurations, if the third data set comprises more than one data entryassociated with the same time, the report may comprise an error message.In some configurations, an error or fault may be indicated on the firstdevice, the second device, and/or another device. In someconfigurations, all of the data entries of the first data set and/or allof the data entries of the second data set may be related to the sameinformation or patient. In some configurations, the third data set maybe sent to the first and/or second devices. In some configurations, thethird data set may be sent to both the first device and the seconddevice. In some such configurations, the third data set may overwritethe first data set and the second data set. Said in another way, thefirst and second data sets may be overwritten by the third data set. Insome configurations, the function of the data entries of the third dataset may comprise an indicator related to the adherence of a patient to atherapy regime. In some such configurations, the indicator may comprisea binary indicator indicating the adherence of the patient to thetherapy regime relative to a threshold level of adherence. In someconfigurations, the indicator may comprise a qualitative indicatorindicating the degree of adherence of a patient to a therapy regime. Insome configurations, the method of data integration may be performed bythe first device and/or by the second device. In some configurations,the method of data integration may be performed by a third device. Thethird device may be remote from the first device and/or the seconddevice. The third device may comprise a computing system, which mayinclude a network of computers (e.g., computers operating a webapplication on the internet), a desktop computer, a laptop computer, atablet, a mobile phone, a ‘smart watch’ or another device. In someconfigurations, the first and second data sets may be associated with apatient. In some such configurations, the same patient may be associatedwith the first and second data sets. In some configurations, if thefirst and second data sets are not associated with the same patient, thereport may comprise an error message. In some configurations, if thefirst and second data sets are not associated with the same patient, afault signal may be generated. In some configurations, the report may beuploaded to a removable memory module or a removable media of the firstand/or second device.

Additionally, in accordance with certain features, aspects andadvantages of at least one of the embodiments disclosed herein, a datamanagement system or apparatus is disclosed. The data management systemmay comprise a controller. The controller may be configured to receive afirst data set from a first device. The first data set may comprise oneor more data entries. One or more of the data entries may be related tothe use of a first medical device, related to the therapy of a patientusing the first medical device, and/or related to a patient using thefirst medical device. One or more of the data entries may be associatedwith a time and/or a position in a sequence of entries. In someconfigurations, each or all of the data entries may be associated with atime and/or a position in a sequence of entries. The controller may beconfigured to receive a second data set from a second device. The seconddata set may comprise one or more data entries. One or more of the dataentries may be related to the use of a second medical device, related tothe therapy of a patient using the second medical device, and/or relatedto a patient using the second medical device. One or more of the dataentries may be associated with a time and/or a position in a sequence ofentries. In some configurations, each or all of the data entries may beassociated with a time and/or a position in the sequence of entries. Thecontroller may be configured to integrate or merge the first data setand the second data set. The integration may lead to the creation of athird data set. The integration may be such that the third data setcomprises the data entries of the first data set and the second dataset. In some configurations, the third data set comprises the dataentries of the first data set and the second data set. In someconfigurations, the data entries are ordered or arranged such that theyare in a temporal sequence with respect to one another. A report may begenerated comprising information related to the third data and/orinformation related to a function of the data entries of the third dataset.

In some configurations, the first device and/or the second device may bemedical devices. In some configurations, both the first and seconddevices are medical devices. In some configurations, the first device isthe first medical device and the second device is the second medicaldevice. In some configurations, the first and second devices are PAPdevices. In some configurations, the report may comprise informationrelated to the adherence of a patient to a therapy regime. In someconfigurations, if the data management system determines that dataentries of the first data set are associated with times that are thesame as times associated with data entries of the second data set, afault signal may be generated. In some configurations, if the third dataset comprises more than one data entry associated with the same time, afault signal may be generated. In some configurations, if the third dataset comprises more than one data entry associated with the same time,the report may comprise an error message. In some configurations, all ofthe data entries of the first data set and all of the data entries ofthe second data set may be related to the same information or patient.In some configurations, the third data set may be sent to the firstand/or second devices. In some configurations, the third data set may besent to both the first device and the second device. In some suchconfigurations, the third data set may overwrite the first data set andthe second data set. Said in another way, the first and second data setsmay be overwritten by the third data set. In some configurations, thefunction of the data entries of the third data set may comprise anindicator related to the adherence of a patient to the therapy regime.In some such configurations, the indicator may comprise a binaryindicator indicating the adherence of the patient to the therapy regimerelative to a threshold level of adherence. In some such configurations,the indicator may comprise a qualitative indicator indicating the degreeof adherence of a patient to a therapy regime. In some configurations,the method of data integration may be performed by the first deviceand/or by the second device. In some configurations, the method of dataintegration may be performed by a third device remote from the firstdevice and the second device. The third device may comprise a computingsystem, which may include a network of computers (e.g. computersoperating a web application on the internet), a desktop computer, alaptop computer, a tablet, a mobile phone, a ‘smart watch’ and/oranother device. In some configurations, the first and second data setsmay be associated with a patient. In some such configurations, the samepatient may be associated with the first and second data sets. In someconfigurations, if the first and second data sets are not associatedwith the same patient, a fault signal may be generated, or if a reportis generated, the report may comprise an error message. In someconfigurations, the report may be uploaded to a removable memory moduleor a removable media of the first and/or second device.

To summarize, and with reference to FIG. 10 , in some configurations, amethod of integrating data is disclosed. In the first step 134, a firstdata set 118 may be received from a first (medical) device 102, thefirst data set 118 comprising one or more data entries related to theuse of the first device 102, related to a patient using the first device102, and/or related to the therapy of a patient using the first device102. Each of the one or more data entries may be associated with a timeand/or position in a sequence of entries. In the second step 136, asecond data set 120 may be received from a second (medical) device 108,the second data set 120 comprising one or more data entries related tothe use of the second device 108, related to a patient using the seconddevice 108, and/or related to the therapy of a patient using the seconddevice 108. In the third step 138, the first data set 118 may beintegrated with the second data set 120 to create a third data set 122.The integration may be such that the third data set 122 comprises thedata entries of the first and second data sets 118, 120. The dataentries may be arranged in a temporal sequence with respect to oneanother. Optionally, in the fourth step 140, a report may be generatedcomprising the third data set 122, the data entries of the third dataset 122, and/or a function of the data entries of the third data set122.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise”, “comprising”, and thelike, are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense, that is to say, in the sense of“including, but not limited to.”

Where, in the foregoing description reference has been made to integersor components having known equivalents thereof, those integers areherein incorporated as if individually set forth.

The invention may also be said broadly to consist in the parts, elementsand features referred to or indicated in the specification of theapplication, individually or collectively, in any or all combinations oftwo or more of said parts, elements or features.

Reference to any prior art in this specification is not, and should notbe taken as, an acknowledgement or any form of suggestion that prior artforms part of the common general knowledge in the field of endeavour inany country in the world.

Certain features, aspects and advantages of some configurations of thepresent disclosure have been described with reference to use by apatient or user. However, certain features, aspects and advantages ofthe data integration method and/or data management system as describedmay be advantageously practiced by other people on behalf of thepatient, including medical professionals, medical device dealers, ormedical device providers. Certain features, aspects and advantages ofthe methods and apparatus of the present disclosure may be equallyapplied to usage by other people.

Additionally, certain features, aspects, and advantages of someconfigurations of the present disclosure have been described as usablewith PAP devices. However, certain features, aspects and advantages ofthe data integration method and/or data management system as describedmay be advantageously practiced with other medical or nonmedical systemsor devices such as insulin pumps, glucose monitors, inhalers, andtreadmills. Certain features, aspects and advantages of the methods andapparatus of the present disclosure may be equally applied to usage withother devices.

Although the present disclosure has been described in terms of certainembodiments, other embodiments apparent to those of ordinary skill inthe art also are within the scope of this disclosure. Thus, variouschanges and modifications may be made without departing from the spiritand scope of the disclosure. For instance, various components may berepositioned as desired. Moreover, not all of the features, aspects andadvantages are necessarily required to practice the present disclosure.Accordingly, the scope of the present disclosure is intended to bedefined only by the claims that follow.

What is claimed is:
 1. A method of monitoring outpatient use of aplurality of medical devices to promote adherence of a patient to atherapy regime, the method comprising: synchronizing a first clock of afirst medical device with a second clock of a second medical device;detecting patient use of at least one of the first medical device andthe second medical device; receiving a first data set comprising datafrom the first medical device; receiving a second data set comprisingdata from the second medical device, wherein the first data set isobtained from the first medical device over a first time period, andwherein the second data set is obtained from a second medical deviceover a second time period, and wherein the first data set and seconddata set are related to the patient's adherence to the therapy regime;comparing the first data set with the second data set; integrating thefirst data set and the second data set to create a third data set,wherein the first data set and the second data set are integrated suchthat the data of the first data set and the data of the second data setare arranged such that the data of the first data set and the data ofthe second data set are in a temporally sequential order with respect toeach another; and generating a report comprising the third data set,wherein the report comprises information summarizing the patient'sadherence to the therapy regime.
 2. The method of claim 1, wherein thereport comprises an indicator derived from the first data set and thesecond data set, the indicator being related to the patient's adherenceto the therapy regime.
 3. The method of claim 2, wherein the indicatoris a binary indicator indicating whether the patient succeeded or didnot succeed in achieving a level of adherence to the therapy regimerelative to a threshold level of adherence.
 4. The method of claim 2,wherein the indicator is a qualitative indicator and is generated bycomparing a degree of adherence to one or more threshold or baselinevalues.
 5. The method of claim 1, wherein the data of the first data setcomprises at least one data block associated with time, and wherein thedata of the second data set comprises at least one data block associatedwith time.
 6. The method of claim 2, wherein comparing the first dataset with the second data set comprises: checking if the first timeperiod and the second time period are the same; and checking whether anyof the data of the first data set has a time stamp that is the same as atime stamp of any of data of the second data set.
 7. The method of claim1, wherein integrating the first data set and the second data set isexecuted by an intermediary device, wherein the intermediary device is amedical device or one of a desktop computer, laptop computer, tablet,mobile phone, wearable computing system, or other personal computingdevice.
 8. The method of claim 1, wherein integrating the first data setand the second data set is executed by at least one of the first medicaldevice or the second medical device.
 9. The method of claim 8, furthercomprising receiving the second data set by the first medical devicefrom the second medical device or receiving the first data set by thesecond medical device from the first medical device.
 10. The method ofclaim 8, wherein integrating the first data set and the second data setis executed by both the first medical device and the second medicaldevice such that each of the first medical device and the second medicaldevice comprise a copy of the third data set.
 11. A system formonitoring outpatient use of a plurality of medical devices to promoteadherence of a patient to a therapy regime, the system comprising: afirst medical device; a second medical device; an intermediary deviceconfigured to communicate with the first medical device and the secondmedical device, the intermediary device configured to integrate datareceived from the first medical device and the second medical device,wherein the intermediary device is configured to: receive a first dataset comprising data from the first medical device obtained over a firsttime period, receive a second data set comprising data from a secondmedical device, obtained over a second time period, and wherein thefirst data set and second data set are related to a patient's adherenceto a therapy regime, compare the first data set with the second dataset, integrate the first data set and the second data set to create athird data set, wherein the first data set and the second data set areintegrated such that the data of the first data set and the data of thesecond data set are arranged such that the data of the first data setand the data of the second data set are in a temporally sequential orderwith respect to one another, and generate a report comprising the thirddata set, wherein the report comprises information summarizing thepatient's adherence to the therapy regime.
 12. The system of claim 11,wherein the report comprises an indicator derived from the first dataset and the second data set, the indicator being related to thepatient's adherence to the therapy regime.
 13. The system of claim 12,wherein the indicator is a binary indicator indicating whether thepatient succeeded or did not succeed in achieving a level of adherenceto the therapy regime relative to a threshold level of adherence. 14.The system of claim 12, wherein the indicator is a qualitative indicatorand is generated by comparing a degree of adherence to one or morethreshold or baseline values.
 15. The system of claim 11, wherein thedata of the first data set comprises at least one data block associatedwith time, and wherein the data of the second data set comprises atleast one data block associated with time.
 16. The system of claim 11,wherein the intermediary device is configured to compare the first dataset with the second data set by: checking if the first time period andthe second time period are the same; and checking whether any of thedata of the first data set has a time stamp that is the same as a timestamp of any of the data of the second data set.
 17. The system of claim11, wherein the intermediary device is a medical device.
 18. The systemof claim 11, wherein the intermediary device is one of a desktopcomputer, laptop computer, tablet, mobile phone, wearable computingsystem, or other personal computing device.
 19. The system of claim 11,wherein at least one of the first medical device and the second medicaldevice comprises a PAP device.
 20. The system of claim 11, wherein thefirst medical device comprises a first communications module and thesecond medical device comprises a second communication module.